Manufacturing Engineer II

• Design, develop, and document manufacturing processes for cable assemblies, fiber optic components, PCBAs, and AV connectivity hardware.
• Lead Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for new and modified manufacturing equipment and processes.
• Define and execute process validation protocols in compliance with ISO 13485 / Class I medical device.
• Conduct and document Measurement System Analysis (MSA) studies including Gage R&R, linearity, and bias assessments to confirm measurement system adequacy.

• Drive NPI activities from concept through production readiness, including process development, tooling qualification, and manufacturing feasibility review.
• Conduct First Article Inspections (FAI) to verify that new and revised products meet engineering drawings, specifications, and customer requirements.
• Collaborate with Engineering and Quality to complete Design for Manufacturability (DFM) reviews during the product development phase.
• Develop and maintain Manufacturing Process Instructions (MPIs), work instructions, traveler documents, and assembly aids for new product launches.

• Define tooling requirements, evaluate vendor-supplied tooling, and manage qualification and ongoing maintenance of manufacturing tools and fixtures.
• Create and execute tool validation plans; maintain documentation in the QMS (QT9) in accordance with change control procedures.
• Coordinate equipment calibration programs with facilities and production, ensuring measuring and test equipment is maintained to applicable standards.

• Conduct on-site supplier visits and process audits to evaluate manufacturing capabilities, quality systems, and compliance with BCI and regulatory requirements.
• Participate in supplier qualification activities including capability assessments and initial sample evaluations.
• Work with the Supplier Quality team to resolve nonconformances, drive corrective actions (SCAR/CAPA), and support supplier development initiatives.

• Champion 5S (Sort, Set in Order, Shine, Standardize, Sustain) implementation and ongoing sustainment across manufacturing and warehouse areas.
• Conduct regular 5S audits, document findings, and drive corrective actions to maintain a safe, organized, and efficient work environment.
• Identify and eliminate the eight wastes through value stream mapping, time studies, and direct observation of production workflows.
• Develop standard work documentation and visual management systems to support sustained Lean practices on the production floor.
• Train and coach production staff on Lean principles, 5S expectations, and waste identification to build a culture of continuous improvement.

• Plan, facilitate, and lead Kaizen events targeting cycle time reduction, yield improvement, scrap reduction, and ergonomic enhancement in manufacturing operations.
• Develop Kaizen event charters, coordinate cross-functional teams, and drive implementation of approved countermeasures through to closure.
• Track and report Kaizen event outcomes and post-event metrics to quantify savings and verify sustained improvement.
• Maintain a continuous improvement pipeline; identify opportunities through data analysis, gemba walks, and employee input.
• Foster a Kaizen mindset across the organization by engaging operators, technicians, and engineers in day-to-day problem solving and incremental improvement.

• Apply Six Sigma DMAIC methodology to define, measure, analyze, improve, and control manufacturing processes with documented tollgate reviews.
• Support or lead Six Sigma projects targeting process variation reduction, defect elimination, and yield improvement aligned with business objectives.
• Mentor production and quality staff on basic Six Sigma concepts and statistical thinking.

• Author and maintain controlled documentation including SOPs, work instructions, validation protocols, and engineering change notices (ECNs) within the QMS.
• Support internal and external ISO 9001 and ISO 13485 audits; participate in management review activities.
• Support investigation and resolution of internal nonconformances and customer complaints through structured root cause analysis (8D, Fishbone, 5-Why).
• Other responsibilities as assigned.

• B.S. in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or equivalent discipline.
• 3–5 years of hands-on manufacturing engineering experience in a regulated environment; medical device or FDA-regulated manufacturing strongly preferred.
• Demonstrated experience executing IQ/OQ/PQ validation protocols in compliance with ISO 13485 or 21 CFR Part 820.
• Hands-on experience with FAI processes and documentation (AS9102 or equivalent frameworks).
• Working knowledge of Measurement System Analysis (MSA/Gage R&R).
• Proven experience implementing 5S programs and sustaining Lean manufacturing practices on an active production floor.
• Six Sigma Green Belt certification required; Black Belt preferred. Demonstrated application of DMAIC on manufacturing improvement projects.
• Familiarity with cable and connector assembly manufacturing, fiber optic termination, or PCBA processes is a significant plus.
• Experience conducting supplier audits and on-site supplier quality visits.
• Proficiency with QMS software (QT9 or equivalent) and ERP systems (Sage 100, NetSuite or equivalent).
• Proficiency in MS Office and statistical analysis tools (Minitab or equivalent).
• Knowledge of IPC-A-610, IPC/WHMA-A-620, and related workmanship standards is preferred.

• Strong organizational skills with high attention to detail and the ability to manage multiple concurrent projects.
• Excellent written and verbal communication skills; ability to author clear, concise technical documentation.
• Self-motivated and able to work with minimal supervision in a fast-paced, small-team environment.
• Collaborative team player with the ability to interface effectively across Engineering, Quality, Production, and Supply Chain.
• Willingness to travel domestically for supplier visits (estimated 10–20%).
• Demonstrated ability to self-learn and adapt quickly to new technologies and product domains.
• Proactive and capable of managing multiple priorities while adapting to changing business needs.
• Comfortable working in a fast-paced, cross-functional team environment, working extended hours (as needed).
• Proficient in Microsoft Excel and working knowledge of Microsoft Office Suite.

• Salary Range: $93,000 - $120,000 (based on experience and qualifications)
• Medical, vision and dental insurance
• 401(k) with company match (100% of the first 4% in eligible compensation)
• Flexible Spending Account
• 2 weeks paid vacation
• 1 Week sick pay
• 10 company holidays
• Group life insurance

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